| CTRI Number |
CTRI/2025/10/096175 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of materials used after root canal treatment |
|
Scientific Title of Study
|
From Lesion to Resolution: A CBCT-Based retrospective study comparing bioactive materials for Non-Surgical Root Canal Therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohil Kale |
| Designation |
PG Student |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics,
College Of Dental Sciences And Research Center, Manipur, Ghuma,
Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9726817619 |
| Fax |
|
| Email |
mohilkale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishtha Patel |
| Designation |
Professor and PG Guide |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics,
College Of Dental Sciences And Research Center, Manipur, Ghuma,
Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishtha Patel |
| Designation |
Professor and PG Guide |
| Affiliation |
College Of Dental Sciences And Research Center |
| Address |
Room No. 7, Department of Conservative Dentistry and Endodontics,
College Of Dental Sciences And Research Center, Manipur, Ghuma,
Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9712994610 |
| Fax |
|
| Email |
dr.nkp.2557@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, College Of Dental Sciences And
Research Center |
|
|
Primary Sponsor
|
| Name |
Mohil Kale |
| Address |
Room No. 7, Department of Conservative Dentistry and
Endodontics,College Of Dental Sciences And Research Center,
Manipur, Ghuma,Ahmedabad, Gujarat, India, 382115 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohil Kale |
College of Dental Sciences and Research center |
Room No.7,
Department of
Conservative Dentistry
And Endodontics,
College of Dental
Sciences And Research
Center, Manipur, Near
Bopal
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
9726817619
mohilkale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College Of Dental Sciences And Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K046||Periapical abscess with sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bioceramic materials |
Bioceramic material is used as a sealer, apical plug (of 5mm) or obturating material after root canal therapy completion |
| Comparator Agent |
Biodentine |
Biodentine is used as a sealer, apical plug (of 5mm) or obturating material after root canal therapy completion |
| Intervention |
Mineral Trioxide Aggregate
(MTA) |
MTA is used as a sealer, apical plug (of 5mm) or obturating material after root canal therapy completion |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with teeth having periapical pathology of more than 4 mm in diameter, having pre-operative and follow up CBCTs available, presence of swelling or sinus tract and teeth with appropriate hard tissue structure left to be restored |
|
| ExclusionCriteria |
| Details |
Cases needing endodontic retreatment, teeth with fractures or perforations and endo-perio lesion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant difference between all three materials |
after 6 months and one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No significant difference between all three materials (MTA, Biodentine, Bioceramics) |
after 6 months & one year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim:-
To
evaluate the effect of non-surgical healing on large periapical lesions of
teeth using bioactive materials with the aid of CBCT scans after a follow up
period of 6 months and 1 year.
Materials
and method:-
A
total of 40 teeth were taken for this retrospective study with single or
multirooted teeth and periapical pathology of more than 4mm in diameter present
with pre-operative and follow-up CBCTs available. All the cases considered
underwent endodontic treatment using one of three bioactive materials (MTA,
Biodentine, Bioceramics). Assessment of healing was done based on radiographic
CBCT scans and CBCT-PAI criteria. The teeth were divided into healing, healed
or diseased based on changes in the CBCT PAI score after 6 months and 1 year.
All the data was recorded in a tabular form and sent for statistical analysis
using chi-square test, t-test and Friedmann’s test.
Results:-
There
was no statistically significant difference in age-wise, gender-wise or
arch-wise distribution. Whilst there was a statistically significant difference
in individual teeth after 6 months and 1 year, with maxillary incisors showing
the highest percentage of healing after 1 year. Increase in healed cases was
also seen across all groups after 1 year. No significant difference was seen
between the use of the three bioactive materials
Conclusion:-
Amongst all the teeth assessed, single rooted
maxillary teeth showed the highest amount of healing. All three Bioactive
materials showed a favourable outcome for the treatment regardless of the
material used |